Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

Rheumatoid Arthritis Clinical Trial

Official title:

LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487565
• Other study ID #: 06005
• Secondary ID: LCS:PS
• Status: Completed
• Phase: N/A
• First received: June 14, 2007
• Last updated: August 6, 2013
• Start date: September 2006
• Est. completion date: February 2011

Study information

• Verified date: August 2013
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Description:

Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• M/F

• 18-80

• Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.

• Skeletally mature, sufficient bone stock to seat and support prosthesis

• Willing/able return for follow-up.

• Subject is willing and able to provide informed patient consent for participation in the study

Exclusion Criteria:

• History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue

• Communicable diseases that may limit follow-up

• Medical-legal or workers compensation claims.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Arthritis
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• Total knee arthroplasty
Total knee arthroplasty using a posterior stabilized implant

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado
United States	Joint Reconstruction Center	Pittsburgh	Pennsylvania
United States	Jordan-Young Institute	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Active Flexion	Active flexion is measured by how much a patient can bend their knee on their own, without assistance.	12 month	No

External Links

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